1. Field of the Invention
The present invention relates to a pharmaceutical preparation administrator and, more particularly, to a device for administrating one or more solid preparations such as freeze-dried solid preparations along with a solvent as a liquid preparation to nasal or eye mucous membranes.
2. Description of the Prior Art
Recently, peptide materials such as peptide hormones and peptide--or polypeptide--bioactive materials, have attracted the attention of many researchers and induced the great interest in development of medical supplies utilizing such peptide materials as they show great drug efficacy is very small quantities. In order to allow the peptide materials to show the drug efficacy in safe, a certain quantity of the drug has to be absorbed into the body at the administration site. However, the most peptide materials, when orally administered, scarcely show the drug efficacy since they are scarcely absorbed in the gastrointestinal tract and have very low bioavailability because of digestion in the GI tract or of the first pass effect taken place at the liver. In addition, an absorption rate of the peptide materials varies greatly with individuals or with dosing intervals, thus making it considerably difficult to ensure the drug efficacy and safety.
For that reason, it would be necessary to administer peptide preparations by injection to obtain high drug efficacy. The injection ensures the delivery of the drug into the body, but it causes pain to a patient and is inconvenient to operate. Thus, in order to administer preparations frequently and safely, there is an increasing demand for development of administration method which ensures high absorption rate of the drug and which may be replaced for injection.
On the other hand, mucosal applications, for example, intranasal administration, inhalation and eye drop administration, have attracted much interest recently as the drugs are absorbed easily through nasal mucous membranes or eye mucous membranes. Further, the mucous application makes it possible to prevent the drug from inactivation at the GI tract in the digestive canal as well as to avoid the first pass effect at the liver. For the purpose of systematic treatment besides rhinitis and allergic coryza, a certain drug is administered in a liquid preparation intranasally with a suitable administering devices such as, for example, spray, tubes, syringe-type devices.
Taking note of advantages in the mucosal applications, it may be a good idea to administer the aforesaid peptide materials in the form of a solution or a suspension to the mucousal membranes by means of a suitable administering device.
However, peptide hormones and peptide--or polypeptide--bioactive materials are considerably unstable in a liquid state, thus making it very difficult to store them as liquid dosage forms such as solutions, suspensions and dispersions. Thus, the peptide materials must be stored in a dry state to keep their drug efficacy even if it is required to administer such a peptide material in a liquid preparation. If the peptide material is formed into a solid preparation such as a freeze-dried form, the solid preparation must be dissolved, or dispersed, or suspended in a solvent such as distilled water just before use to form a solution, or a suspension, or a dispersion. In addition, the resultant liquid preparation must be charged into a suitable administrating device such as syringes, spray containers, tubes, pipettes and the like to administer it by dropping or spraying. Thus, this method is disadvantageous in that operation is very troublesome and inconvenient.
For injection, it has been proposed to use a syringe comprising a cylinder including powder and a solvent separated by a rubber plug arranged in the cylinder. In use, the solvent is forced to flow into a front powder chamber of the cylinder where the powder contained therein is dissolved in the solvent, and the resultant solution is injected into the human body. Such a pre-filled syringe makes it possible to dissolve the tablet in the solvent by itself, so that there is no need to charge the solution into the syringe. It is, however, impossible to apply such a syringe to administration of peptide preparations as a non-parenteral application because of its structure.
Further, it is difficult with the conventional administrating devices such as spraying devices to administer a very small quantity of the liquid preparation correctly, as well as to administer all the liquid preparation contained therein because of its structure. For that reason, a part of the unused preparation is thrown into the discard together with the administrating device. If such a device is applied to administration of the peptide materials, it is very wasteful as the peptide materials are very expensive. In addition, since the administrating devices of the prior art are designed on condition that they are used repeatedly, there is the possibility of bacteriological contamination of the device during repeated use. In order to avoid the bacteriological contamination, it is required to rinse the administrating device at regular intervals, thus making it very troublesome to handle. In addition, it is difficult with the rinsing operation to sufficiently prevent the administrating device from having bacteriological contamination. To this end, it is obliged to add preservative or antiseptic to the preparation. However, chemicals generally used as the preservative or antiseptic have a strong irritating action for mucous membrane, so that there is the possibility of disturbance of mucous membranes.